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RECRUITING

NCT07691957

Microneurography and Intraneural Microstimulation for Upper Limb Sensory Investigation in Healthy and Amputee Subjects

Sponsor: Azienda Ospedaliero, Universitaria Pisana

View on ClinicalTrials.gov

Summary

The goal of this experimental study is to investigate the somatosensory system through intraneural recording and stimulation of the median nerve in healthy volunteers and participants with upper-limb amputation. The main questions it aims to answer are: * How does median nerve activity encode tactile perception during different types of mechanical tactile stimulation in healthy subjects? * How can tactile information be artificially encoded and restored through intraneural microstimulation in both healthy subjects and upper-limb amputee participants? How rich and functionally meaningful is the restored sensory information? * What are the neurophysiological mechanisms underlying tactile stimulus processing and the associated patterns of brain activation during tactile stimulation? Participants will undergo median nerve recordings using microneurography during controlled mechanical tactile stimulation, as well as intraneural microstimulation with specific patterns to evoke near-natural tactile sensations. They will perform perceptual reporting tasks related to stimulus type, intensity, and localization, as well as psychophysical tests under different stimulation conditions. When possible, they will also undergo non-invasive recordings of brain activity using electroencephalography during sensory stimulation.

Official title: Experimental Study to Investigate Sensory Control of the Upper Limb Through Microneurography and to Restore Near-natural Tactile Sensations Through Intraneural Microstimulation in Healthy and Amputee Subjects

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-03-04

Completion Date

2026-12-31

Last Updated

2026-07-09

Healthy Volunteers

Yes

Conditions

Upper Limb Amputation Healthy Subjects

Interventions

PROCEDURE

Microneurography

Microneurography is a minimally invasive neurophysiological technique that allows direct recording of the electrical activity of single peripheral nerve fibers using specific microelectrodes inserted into the nerve.

PROCEDURE

Intraneural Microstimulation

Intraneural microstimulation is a minimally invasive neurophysiological technique in which small electrical currents are delivered through a microelectrode inserted into a peripheral nerve to selectively activate nerve fibers and evoke sensory perceptions.

Inclusion Criteria: Healthy participants * Age between 18-60 years, of any sex * Signed informed consent * No neurological diseases * Presence of both intact upper limbs * Normal language, visuospatial, and general intellectual abilities, assessed using the Wechsler Adult Intelligence Scale-Revised (WAIS-R) (Appendix 1) Amputee participants * Age between 18-60 years, of any sex * Signed informed consent * Upper-limb amputation (transradial or hand amputation) * Stable amputation for at least one year * Normal language, visuospatial, and general intellectual abilities, assessed using the Wechsler Adult Intelligence Scale-Revised (WAIS-R) (Appendix 1) * Evidence of residual peripheral nerve function in the stump, based on nerve conduction studies as documented in clinical records Exclusion Criteria: Healthy participants * Conditions affecting perceptual abilities * Inability to provide informed consent * Pregnancy or breastfeeding (self-reported) * Clinical conditions that, in the judgment of the investigator responsible for recruitment, may interfere with microneurography, microstimulation, and EEG procedures * Current or past substance abuse * Brain injury with residual motor impairment * Depression * Presence of neurological or musculoskeletal disorders * Diabetes mellitus * Current or previous dermatological conditions * Morphological nerve abnormalities, as indicated by ultrasound or MRI findings in clinical records * Upper-limb amputation Amputee participants * Psychological and/or cognitive disorders * Inability to provide informed consent * Pregnancy or breastfeeding (self-reported) * Clinical conditions that, in the judgment of the investigator responsible for recruitment, may interfere with microneurography, microstimulation, and EEG procedures * Current or past substance abuse * Brain injury with residual motor impairment * Depression * Presence of neurological or musculoskeletal disorders * Diabetes mellitus * Current or previous dermatological conditions * Morphological nerve abnormalities, as indicated by ultrasound or MRI findings in clinical records * Bilateral upper-limb amputation

Locations (1)

Laboratorio Congiunto di Microneurografia e Microneurostimolazione

Pisa, Pisa, Italy